The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Api Uniscept Mic/type 2 And 3 And Micro Mic.
| Device ID | K923684 |
| 510k Number | K923684 |
| Device Name: | API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | ANALYTICAL PRODUCTS, INC. 200 EXPRESS STREET Plainview , NY 11803 - |
| Contact | Valerie L Vargo |
| Correspondent | Valerie L Vargo ANALYTICAL PRODUCTS, INC. 200 EXPRESS STREET Plainview , NY 11803 - |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-23 |
| Decision Date | 1992-12-03 |